Off-label use of migraine drug gives children relief, study says

03/08/04

COLUMBUS, Ohio A new study suggests that when over-the-counter medications fail to help children who suffer from chronic migraine headaches, those children may find relief with a drug traditionally prescribed to adults.

Around one out of every 10 children experience chronic migraines, said Ann Pakalnis, a study co-author and a clinical associate professor of pediatrics and neurology at Ohio State University and Columbus Children's Hospital.

She and her colleagues treated 57 children with sumatriptan (Imitrex) nasal spray. More than three-quarters of the families in the study reported good to excellent relief of their child's headaches after using the spray, and nearly 100 percent of the children in these families continued using the drug.

But sumatriptan isn't approved by the U.S. Food and Drug Administration for use in children. The participants in this study were prescribed sumatriptan on an off-label basis, a common practice in which a medication is used to treat a group of people or a problem it wasn't originally intended to treat.

"By the time children see us at the headache clinic, they've already tried over-the-counter medications or milder prescription drugs," said Pakalnis. "Their parents want a more aggressive treatment. They understand that it's probably the best thing to do for their child, even if means an off-label use."

The findings appear in a recent issue of the Journal of Child Neurology. Pakalnis conducted the study with Donna Kring, a nurse at Columbus Children's Hospital, and Juliann Paolicchi, a pediatrician at the hospital.

The researchers took a retrospective approach to appraising sumatriptan's effectiveness in children. They reviewed the medical charts of children 5 to 12 years old who were patients at Columbus Children's Hospital, tallying the number of children prescribed the nasal spray. Each child's family then received a questionnaire asking about the child's use of the spray, its effectiveness and any concerns regarding the off-label use of the drug.

The majority (77 percent) of the 57 families who responded to the questionnaire reported that sumatriptan nasal spray had significantly helped their child, and 93 percent of these families noted that their child still used the drug.

Thirteen patients (23 percent) reported side effects from using the spray. Each of these children said the spray tasted bad, and five in this group stopped using it altogether. Sumatriptan nasal spray tastes very bitter and metallic to some children, Pakalnis said. Four of the 13 patients complained of dizziness. Two children found the spray difficult to use, and stopped using it.

"A nasal spray is the preferred way to deliver sumatriptan to children as their migraines tend to be very short, and the spray starts working in about 15 minutes," Pakalnis said. "Some kids have a lot of nausea and vomiting with their headaches, which rules out giving them a tablet. Injection is another choice, but not a great option for children."

Migraine triggers such as dehydration, fatigue and hormonal changes cause changes in nerve impulses that in turn affect blood vessel diameter and biochemical release. Blood vessel dilation causes pain, which analgesics can help alleviate. But analgesics don't address the symptoms that often accompany migraines, such as nausea, vomiting and sensitivity to light and sound, which are usually caused by blood vessel constriction.

Sumatriptan and related drugs stop pain by restoring the nervous system's ability to block pain impulses and help constrict blood vessels. And the triptans also help dilate the constricted vessels that contribute to they symptoms that accompany migraine attacks.

About 30 percent of the patients coming to Pakalnis' office seek help for migraines. She and her colleagues currently prescribe sumatriptan nasal spray to about three-quarters of these patients.

"It's an effective and safe treatment for children who don't respond to over-the-counter pain killers," she said.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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